Treatment of SSRI-Resistant Depression In Adolescents (TORDIA) (TORDIA)
11 de marzo de 2014 actualizado por: University of Pittsburgh
Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)
The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried.
Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The TORDIA study aims to develop useful clinical guidelines for the care and management of adolescent depression.
Adolescents ages 12 to 18, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) and still experiencing depression, participate in a 12-week randomized treatment study that includes one of four conditions: (1) switching to an alternative SSRI, (2) switching to a different non-SSRI antidepressant, (3) switching to an alternative SSRI and receiving cognitive behavioral therapy (CBT), or (4) switching to a different non-SSRI antidepressant and receiving CBT.
This is a double-blind study, which means that neither the participant nor the clinical staff will know which of the three possible medications has been assigned.
Participants who respond to the assigned treatment will receive 12 additional weeks of the same treatment.
Those who do not appear to be getting better will be offered 12 weeks of an alternative, individualized treatment plan based on each participant's particular needs.
All participants will receive follow-up psychiatric evaluations for 12 months after the 12-week continuation phase of the study, regardless of treatment adherence.
Tipo de estudio
Intervencionista
Inscripción (Actual)
334
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095-6967
- University of California at Los Angeles
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Oregon
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Portland, Oregon, Estados Unidos, 97227-1098
- Kaiser Permanente Center for Health Research
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02906
- Brown University
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Texas
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Dallas, Texas, Estados Unidos, 75390-8589
- University of Texas - Southwestern Medical Center
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Galveston, Texas, Estados Unidos, 77555-0188
- University of Texas Medical Branch
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
- between the ages of 12 and 18 years 11 months
- currently in treatment for depression
- taking Prozac,Zoloft, Luvox, Lexapro, Celexa or Paxil (Oregon and Rhode Island sites only)
- still feeling depressed
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 1
Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI.
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Standard anti-depressant treatment with the SSRI fluoxetine
Otros nombres:
Standard anti-depressant treatment with the SSRI fluoxetine
Otros nombres:
|
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Experimental: 2
Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant.
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Standard antidepressant treatment with the non-SSRI medication venlafaxine
Otros nombres:
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Experimental: 3
Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT).
|
Standard anti-depressant treatment with the SSRI fluoxetine
Otros nombres:
Standard anti-depressant treatment with the SSRI fluoxetine
Otros nombres:
CBT addresses maladaptive beliefs in order to encourage behavioral change
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Experimental: 4
Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant and receive CBT.
|
Standard antidepressant treatment with the non-SSRI medication venlafaxine
Otros nombres:
CBT addresses maladaptive beliefs in order to encourage behavioral change
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David A. Brent, MD, Western Psychiatric Institute and Clinic (Data Coordinating Center)
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Brent DA, Holder D, Kolko D, Birmaher B, Baugher M, Roth C, Iyengar S, Johnson BA. A clinical psychotherapy trial for adolescent depression comparing cognitive, family, and supportive therapy. Arch Gen Psychiatry. 1997 Sep;54(9):877-85. doi: 10.1001/archpsyc.1997.01830210125017.
- Emslie GJ, Rush AJ, Weinberg WA, Kowatch RA, Hughes CW, Carmody T, Rintelmann J. A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression. Arch Gen Psychiatry. 1997 Nov;54(11):1031-7. doi: 10.1001/archpsyc.1997.01830230069010.
- Keller MB, Ryan ND, Birmaher B, Klein RG, Strober M, Wagner KD, Weller EB: Paroxetine and imipramine in the treatment of adolescent depression. New Research Program Abstracts. Annual Meeting of the American Psychiatric Association [123], 1998.
- Wagner KD, Asarnow JR, Vitiello B, Clarke G, Keller M, Emslie GJ, Ryan N, Porta G, Iyengar S, Ritz L, Zelanzny J, Onorato M, Brent D. Out of the black box: treatment of resistant depression in adolescents and the antidepressant controversy. J Child Adolesc Psychopharmacol. 2012 Feb;22(1):5-10. doi: 10.1089/cap.2011.0045. Epub 2012 Jan 17. Erratum In: J Child Adolesc Psychopharmacol. 2019 Aug;29(7):574.
- Brent D, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller M, Vitiello B, Ritz L, Iyengar S, Abebe K, Birmaher B, Ryan N, Kennard B, Hughes C, DeBar L, McCracken J, Strober M, Suddath R, Spirito A, Leonard H, Melhem N, Porta G, Onorato M, Zelazny J. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008 Feb 27;299(8):901-913. doi: 10.1001/jama.299.8.901. Erratum In: JAMA. 2019 Nov 5;322(17):1718.
- Brent DA, Emslie GJ, Clarke GN, Asarnow J, Spirito A, Ritz L, Vitiello B, Iyengar S, Birmaher B, Ryan ND, Zelazny J, Onorato M, Kennard B, Mayes TL, Debar LL, McCracken JT, Strober M, Suddath R, Leonard H, Porta G, Keller MB. Predictors of spontaneous and systematically assessed suicidal adverse events in the treatment of SSRI-resistant depression in adolescents (TORDIA) study. Am J Psychiatry. 2009 Apr;166(4):418-26. doi: 10.1176/appi.ajp.2008.08070976. Epub 2009 Feb 17. Erratum In: Am J Psychiatry. 2019 Sep 1;176(9):764.
- Asarnow JR, Emslie G, Clarke G, Wagner KD, Spirito A, Vitiello B, Iyengar S, Shamseddeen W, Ritz L, Birmaher B, Ryan N, Kennard B, Mayes T, DeBar L, McCracken J, Strober M, Suddath R, Leonard H, Porta G, Keller M, Brent D. Treatment of selective serotonin reuptake inhibitor-resistant depression in adolescents: predictors and moderators of treatment response. J Am Acad Child Adolesc Psychiatry. 2009 Mar;48(3):330-339. doi: 10.1097/chi.0b013e3181977476.
- Goldstein BI, Shamseddeen W, Spirito A, Emslie G, Clarke G, Wagner KD, Asarnow JR, Vitiello B, Ryan N, Birmaher B, Mayes T, Onorato M, Zelazny J, Brent DA. Substance use and the treatment of resistant depression in adolescents. J Am Acad Child Adolesc Psychiatry. 2009 Dec;48(12):1182-92. doi: 10.1097/CHI.0b013e3181bef6e8.
- Spirito A, Abebe KZ, Iyengar S, Brent D, Vitiello B, Clarke G, Wagner KD, Asarnow J, Emslie G, Keller M. Sources of site differences in the efficacy of a multisite clinical trial: the Treatment of SSRI-Resistant Depression in Adolescents. J Consult Clin Psychol. 2009 Jun;77(3):439-50. doi: 10.1037/a0014834.
- Kennard BD, Clarke GN, Weersing VR, Asarnow JR, Shamseddeen W, Porta G, Berk M, Hughes JL, Spirito A, Emslie GJ, Keller MB, Wagner KD, Brent DA. Effective components of TORDIA cognitive-behavioral therapy for adolescent depression: preliminary findings. J Consult Clin Psychol. 2009 Dec;77(6):1033-41. doi: 10.1037/a0017411.
- Brent D, Melhem N, Ferrell R, Emslie G, Wagner KD, Ryan N, Vitiello B, Birmaher B, Mayes T, Zelazny J, Onorato M, Devlin B, Clarke G, DeBar L, Keller M. Association of FKBP5 polymorphisms with suicidal events in the Treatment of Resistant Depression in Adolescents (TORDIA) study. Am J Psychiatry. 2010 Feb;167(2):190-7. doi: 10.1176/appi.ajp.2009.09040576. Epub 2009 Dec 15.
- Emslie GJ, Mayes T, Porta G, Vitiello B, Clarke G, Wagner KD, Asarnow JR, Spirito A, Birmaher B, Ryan N, Kennard B, DeBar L, McCracken J, Strober M, Onorato M, Zelazny J, Keller M, Iyengar S, Brent D. Treatment of Resistant Depression in Adolescents (TORDIA): week 24 outcomes. Am J Psychiatry. 2010 Jul;167(7):782-91. doi: 10.1176/appi.ajp.2010.09040552. Epub 2010 May 17.
- Asarnow JR, Porta G, Spirito A, Emslie G, Clarke G, Wagner KD, Vitiello B, Keller M, Birmaher B, McCracken J, Mayes T, Berk M, Brent DA. Suicide attempts and nonsuicidal self-injury in the treatment of resistant depression in adolescents: findings from the TORDIA study. J Am Acad Child Adolesc Psychiatry. 2011 Aug;50(8):772-81. doi: 10.1016/j.jaac.2011.04.003. Epub 2011 Jun 11.
- Sakolsky DJ, Perel JM, Emslie GJ, Clarke GN, Wagner KD, Vitiello B, Keller MB, Birmaher B, Asarnow JR, Ryan ND, McCracken JT, Strober MJ, Iyengar S, Porta G, Brent DA. Antidepressant exposure as a predictor of clinical outcomes in the Treatment of Resistant Depression in Adolescents (TORDIA) study. J Clin Psychopharmacol. 2011 Feb;31(1):92-7. doi: 10.1097/JCP.0b013e318204b117.
- Shamseddeen W, Asarnow JR, Clarke G, Vitiello B, Wagner KD, Birmaher B, Keller MB, Emslie G, Iyengar S, Ryan ND, McCracken JT, Porta G, Mayes T, Brent DA. Impact of physical and sexual abuse on treatment response in the Treatment of Resistant Depression in Adolescent Study (TORDIA). J Am Acad Child Adolesc Psychiatry. 2011 Mar;50(3):293-301. doi: 10.1016/j.jaac.2010.11.019. Epub 2011 Jan 14. Erratum In: J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):454-463.
- Vitiello B, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller MB, Birmaher B, Ryan ND, Kennard B, Mayes TL, DeBar L, Lynch F, Dickerson J, Strober M, Suddath R, McCracken JT, Spirito A, Onorato M, Zelazny J, Porta G, Iyengar S, Brent DA. Long-term outcome of adolescent depression initially resistant to selective serotonin reuptake inhibitor treatment: a follow-up study of the TORDIA sample. J Clin Psychiatry. 2011 Mar;72(3):388-96. doi: 10.4088/JCP.09m05885blu. Erratum In: J Clin Psychiatry. 2019 Oct 23;80(5):
- Woldu H, Porta G, Goldstein T, Sakolsky D, Perel J, Emslie G, Mayes T, Clarke G, Ryan ND, Birmaher B, Wagner KD, Asarnow JR, Keller MB, Brent D. Pharmacokinetically and clinician-determined adherence to an antidepressant regimen and clinical outcome in the TORDIA trial. J Am Acad Child Adolesc Psychiatry. 2011 May;50(5):490-8. doi: 10.1016/j.jaac.2011.01.018. Epub 2011 Mar 9.
- Maalouf FT, Porta G, Vitiello B, Emslie G, Mayes T, Clarke G, Wagner KD, Asarnow JR, Spirito A, Keller M, Birmaher B, Ryan N, Shamseddeen W, Iyengar S, Brent D. Do sub-syndromal manic symptoms influence outcome in treatment resistant depression in adolescents? A latent class analysis from the TORDIA study. J Affect Disord. 2012 Apr;138(1-2):86-95. doi: 10.1016/j.jad.2011.12.021. Epub 2012 Jan 30. Erratum In: J Affect Disord. 2019 Nov 1;258:55.
- Lynch FL, Dickerson JF, Clarke G, Vitiello B, Porta G, Wagner KD, Emslie G, Asarnow JR Jr, Keller MB, Birmaher B, Ryan ND, Kennard B, Mayes T, DeBar L, McCracken JT, Strober M, Suddath RL, Spirito A, Onorato M, Zelazny J, Iyengar S, Brent D. Incremental cost-effectiveness of combined therapy vs medication only for youth with selective serotonin reuptake inhibitor-resistant depression: treatment of SSRI-resistant depression in adolescents trial findings. Arch Gen Psychiatry. 2011 Mar;68(3):253-62. doi: 10.1001/archgenpsychiatry.2011.9.
- Shamseddeen W, Clarke G, Wagner KD, Ryan ND, Birmaher B, Emslie G, Asarnow JR, Porta G, Mayes T, Keller MB, Brent DA. Treatment-resistant depressed youth show a higher response rate if treatment ends during summer school break. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1140-8. doi: 10.1016/j.jaac.2011.07.022. Epub 2011 Sep 9.
- Shamseddeen W, Clarke G, Keller MB, Wagner KD, Birmaher B, Emslie GJ, Ryan N, Asarnow JR, Porta G, Brent DA. Adjunctive sleep medications and depression outcome in the treatment of serotonin-selective reuptake inhibitor resistant depression in adolescents study. J Child Adolesc Psychopharmacol. 2012 Feb;22(1):29-36. doi: 10.1089/cap.2011.0027. Epub 2012 Jan 17. Erratum In: J Child Adolesc Psychopharmacol. 2019 Aug;29(7):573.
- McMakin DL, Olino TM, Porta G, Dietz LJ, Emslie G, Clarke G, Wagner KD, Asarnow JR, Ryan ND, Birmaher B, Shamseddeen W, Mayes T, Kennard B, Spirito A, Keller M, Lynch FL, Dickerson JF, Brent DA. Anhedonia predicts poorer recovery among youth with selective serotonin reuptake inhibitor treatment-resistant depression. J Am Acad Child Adolesc Psychiatry. 2012 Apr;51(4):404-11. doi: 10.1016/j.jaac.2012.01.011. Epub 2012 Mar 3.
- Rengasamy M, Mansoor BM, Hilton R, Porta G, He J, Emslie GJ, Mayes T, Clarke GN, Wagner KD, Keller MB, Ryan ND, Birmaher B, Shamseddeen W, Asarnow JR, Brent DA. The bi-directional relationship between parent-child conflict and treatment outcome in treatment-resistant adolescent depression. J Am Acad Child Adolesc Psychiatry. 2013 Apr;52(4):370-7. doi: 10.1016/j.jaac.2013.01.012.
- Hilton RC, Rengasamy M, Mansoor B, He J, Mayes T, Emslie GJ, Porta G, Clarke GN, Wagner KD, Birmaher B, Keller MB, Ryan N, Shamseddeen W, Asarnow JR, Brent DA. Impact of treatments for depression on comorbid anxiety, attentional, and behavioral symptoms in adolescents with selective serotonin reuptake inhibitor-resistant depression. J Am Acad Child Adolesc Psychiatry. 2013 May;52(5):482-92. doi: 10.1016/j.jaac.2013.02.013. Epub 2013 Apr 4.
- Mansoor B, Rengasamy M, Hilton R, Porta G, He J, Spirito A, Emslie GJ, Mayes TL, Clarke G, Wagner KD, Shamseddeen W, Birmaher B, Ryan N, Brent D. The bidirectional relationship between body mass index and treatment outcome in adolescents with treatment-resistant depression. J Child Adolesc Psychopharmacol. 2013 Sep;23(7):458-67. doi: 10.1089/cap.2012.0095. Epub 2013 Sep 11.
- Perloe A, Esposito-Smythers C, Curby TW, Renshaw KD. Concurrent trajectories of change in adolescent and maternal depressive symptoms in the TORDIA study. J Youth Adolesc. 2014 Apr;43(4):612-28. doi: 10.1007/s10964-013-9999-0. Epub 2013 Aug 22.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2001
Finalización primaria (Actual)
1 de marzo de 2007
Finalización del estudio (Actual)
1 de marzo de 2007
Fechas de registro del estudio
Enviado por primera vez
10 de julio de 2001
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2001
Publicado por primera vez (Estimar)
12 de julio de 2001
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de marzo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
11 de marzo de 2014
Última verificación
1 de marzo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Desordenes mentales
- Trastornos del estado de ánimo
- Depresión
- Desorden depresivo
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Drogas psicotropicas
- Inhibidores de la captación de serotonina
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes de serotonina
- Agentes antidepresivos
- Inhibidores de enzimas del citocromo P-450
- Agentes antidepresivos, segunda generación
- Inhibidores de la recaptación de serotonina y noradrenalina
- Inhibidores del citocromo P-450 CYP2D6
- Citalopram
- Clorhidrato de venlafaxina
- Fluoxetina
Otros números de identificación del estudio
- U01MH061835 (Subvención/contrato del NIH de EE. UU.)
- TORDIA
- DSIR B4-ARD
- MH61835
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .